FDA Inspection
Austin Respiratory Dba Austin MedicalAustin Respiratory Dba Austin Medical – FDA Inspection, Jul 14, 2010
Record Details
This FDA Inspection record concerns Austin Respiratory Dba Austin Medical, with an inspection on July 14, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 14, 2010
- Product Type
- Drugs
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ID · e54c41ab-5798-44ad-9687-7fcc657012b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672404
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
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